Firmware Developer - Medical Device
AiTA Bio Inc.
Company Overview
AiTA Bio Inc. is developing a Class C medical device that requires safety critical embedded systems development. We're seeking an experienced and versatile firmware developer who thrives in a fast-paced startup environment where adaptability and innovation are essential.
Position Overview
This developer will oversee the design, development, and maintenance of the embedded codebase for a Class C medical device. The hardware is centered around the Nordic family of BLE SoC microcontrollers. This role requires someone who can wear multiple hats, adapt quickly to evolving requirements, and contribute to both architecture and implementation while maintaining the rigorous standards required for medical device development. A strong commitment to test-driven development and comprehensive testing practices is essential.
Key Responsibilities
* Design and implement firmware using the Nordic port of ZephyrOS
* Synchronize firmware with hardware development
* Develop and maintain comprehensive unit tests and integration tests for all firmware components following the AiTA Software Development Plan
* Maintain CI/CD pipelines for automated build, test, and deployment processes
* Develop and maintain Bluetooth Low Energy (BLE) communication protocols with both standard and custom GATT services
* Implement real-time control systems for safety-critical medical device operations
* Collaborate with hardware, systems, and clinical teams to refine requirements and resolve integration challenges
* Contribute to design documentation, risk analysis, and verification activities to support FDA/regulatory submissions
* Build testable, modular code architectures that facilitate automated testing
* Adapt quickly to changing product requirements and technical priorities
* Participate in design reviews, code reviews, and testing protocols
Required Qualifications
* Strong C programming expertise with comprehensive understanding of embedded systems
* Hands-on experience with Zephyr RTOS or similar RTOS environments (FreeRTOS, ThreadX)
* Proficiency in Python for test automation, tooling, and build scripts
* Experience reading schematics and understanding the interaction between hardware and firmware
* Proven experience with test-driven development (TDD) in embedded systems including white-box testing techniques (code coverage analysis, boundary testing, and fault injection) as well as rigorous unit and integration testing
* Hands-on experience with embedded testing frameworks (Unity, CMock, ZTest similar)
* Experience in safety-critical systems development (medical, automotive, or aerospace)
* Experience with real-time systems, interrupts, and low-power design
* Proficiency with debugging tools (J-Link, oscilloscopes, logic analyzers)
* Experience with version control (Git) and collaborative development workflows
* Strong problem-solving skills and ability to work independently
* Excellent communication skills for cross-functional collaboration
Highly Desirable
* Experience with Zephyr's native testing frameworks (Ztest)
* Experience with Nordic's ZephyrOS port
* Experience with CI/CD platforms and pipelines for embedded system (GitHub Actions, GitLab CI, Jenkins, Azure DevOps)
* Experience with continuous integration/continuous testing (CI/CT) pipelines for embedded systems
* Knowledge of code coverage tools and static analysis (Gcov, LCOV, Coverity, PC-Lint, Cppcheck)
* Experience with hardware-in-the-loop (HIL) testing and test automation
* Familiarity with mock/stub frameworks for embedded systems testing
* Python experience with pytest, scripting, and automation tools
* Bluetooth Low Energy (BLE) development experience including GATT services, connection management, and optimization
* Experience with containerization (Docker) for reproducible build environments
* Knowledge of Device Tree configuration in Zephyr
* Understanding of cybersecurity requirements for safety-critical devices
* Experience with power management and battery-operated devices
* FMEA, FTA, or hazard analysis experience
* Familiarity with FDA regulations (21 CFR Part 820, Design Controls) or equivalent standards
Safety-Critical Systems Experience
We highly value experience from automotive, aerospace, or medical device industries equally. Each of these domains provides excellent preparation for our work:
Automotive experience (ASIL-rated systems, ISO 26262):
* Functional safety and hazard analysis methodologies
* Rigorous V&V processes and traceability requirements
* Safety-critical real-time control systems
* Systematic approach to failure modes and fault handling
Aerospace experience (DO-178C, DO-254):
* High-reliability embedded systems development
* Exhaustive testing and verification practices
* Configuration management and requirements traceability
* Certification processes and documentation rigor
* Safety-critical software development lifecycle
Medical device experience (IEC 62304, ISO 14971, ISO 13485):
* FDA regulatory compliance and design controls
* Risk management for medical applications
* Design verification and validation for clinical use
* Usability engineering and human factors
* Understanding of biocompatibility and patient safety
What matters most:
Regardless of which industry you come from, we're looking for demonstrated experience with systematic development processes, safety analysis, requirements traceability, and rigorous testing in environments where failure is not an option.
Testing Philosophy & Approach
We believe that comprehensive testing is not just a validation activity—it's integral to how we design and build firmware. We expect our firmware developers to:
* Write tests before or alongside production code
* Design for testability with clear interfaces and minimal dependencies
* Achieve high code coverage through meaningful unit tests
* Create integration tests that validate component interactions
* Use white-box testing to verify internal logic paths and error handling
* Build regression test suites that run automatically on every commit
* Document test strategies and maintain traceability to requirements
* Leverage CI/CD pipelines to catch issues early and maintain code quality
Startup Environment Skills
* Adaptability: Comfortable with pivoting based on user feedback, regulatory guidance, or technical constraints
* Ownership mentality: Self-directed and able to drive projects from concept to completion
* Pragmatism: Balancing ideal solutions with practical constraints and timelines
* Learning agility: Quick to pick up new technologies, tools, and domain knowledge
* Collaborative problem-solving: Working effectively with limited resources and with a wide range of stakeholders
What We Offer
We're a passionate and driven team dedicated to advancing and developing innovative solutions that improve health and quality of life.
Our benefits include:
* Comprehensive health coverage, including medical, dental, and vision insurance
* 401(k) plan available to all employees
* Paid time off, including vacation, sick days, and company holidays
* Equity participation in a growing startup
* Opportunity to make a direct impact on patient health outcomes
* Work on cutting-edge medical technology with real-world applications
* Dynamic and innovative workplace that encourages ideas, professional growth, and cross-functional learning
Experience
Formal education and degrees are desired but not required. Extensive real world experience building safety critical apps is a must.